Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

Phase 3 Completed 100 enrolled UCB BIOSCIENCES, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.

Timeline

Start: 2008-04
Primary completion: 2009-09
Completion: 2009-09

Publications

Results Fountain NB, Krauss G, Isojarvi J, Dilley D, Doty P, Rudd GD. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures. Epilepsia. 2013 Jan;54(1):58-65. doi: 10.1111/j.1528-1167.2012.03543.x. Epub 2012 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lacosamide	Other / unclassified	200 mg	Intravenous
Subject	Lacosamide	Other / unclassified	300 mg	Intravenous
Subject	Lacosamide	Other / unclassified	400 mg	Intravenous

Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

Summary

Timeline

Publications

Drugs

Indications